Simultaneous method development and validation for estimation of fosnetupitant and palonosetron using HPLC

Abstract

Akynzeo injection dosage form containing 0.25 mg and 235 mg of palonosetron and fosnetupitant, respectively is recently approved in US, used in adults for the avoidance of delayed and acute nausea and vomiting during chemotherapy in emetogenic cancer. In this investigation, a reverse phase high pressure liquid chromatography method for quantification of palonosetron and fosnetupitant simultaneously is developed and validated. The separation of palonosetron and fosnetupitant was accomplished using 0.1M NaH2PO4 - methanol (60:40, v/v) as mobile phase and Kromosil, C18 (25 cm × 4.6 mm, 5µm) as analytical column. Quantitation of palonosetron and fosnetupitant was by photodiode array detector at 225 nm in the amount range of 235-705 µg/ml (fosnetupitant) and 0.25-0.75 µg/ml (palonosetron). Using described conditions of chromatography, the method shown good resolution and separation of fosnetupitant and palonosetron with retention time of 3.034 min and 4.779 min, respectively. Detection & quantification limits for palonosetron and fosnetupitant were calculated as 0.0245 µg/ml & 0.0817 µg/ml and 1.219 µg/ml & 4.062 µg/ml, respectively. For accuracy and precision that are expressed as relative standard deviation and percent respectively, the found values are satisfactory and acceptable as given by ICH.Recovery assay carried out for samples gave recoveries of 99.65% and 99.29% 102.5% and 95.2% for fosnetupitant and palonosetron, respectively. In conclusion, a reliable and suitable and reliable procedure for simultaneous estimation of fosnetupitant and palonosetron using RP-HPLC technique was developed & validated successfully.